HypotensionHypoTAShoulderNCT03451565
Intraoperative Systemic Arterial Hypotension Secondary to Beach Positioning
An observational study of Hypotension, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This study aims at describing the systemic arterial hypotension secondary to intraoperative beach chair positioning. This is a non-interventional prospective study. The primary endpoint will be the intraoperative systemic arterial pressure measured at the arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2018to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population studied will include patients operated at the University Hospitals of Strasbourg in a sitting position.
Who may be able to join
- Age above 18 years
- Patient operated in a sitting position at Hopitaux Universitaires de Strasbourg
- Patient willing to participate in the study
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service D'Anesthesiologie - Reanimation Chirurgicale
Strasbourg, 67098
Eric Noll, MD, 33 3 88 55 23 37, eric.noll@chru-strasbourg.fr
Pierre Diemunsch, MD, PhD, 33 3 88 12 70 76, pierre.diemunsch@chru-strasbourg.fr
About this study
Official title: Intraoperative Systemic Arterial Hypotension Secondary to Beach Positioning : an Observational Study
This study aims at describing the systemic arterial hypotension secondary to intraoperative beach chair positioning. This is a non-interventional prospective study.
The primary endpoint will be the intraoperative systemic arterial pressure measured at the arm.
The secondary endpoints will include postoperative mortality, intensive care admission, post anesthesia care unit length of stay,
- Conditions
- Hypotension
- Keywords
- Hypotension, Systemic blood pressure
- Medical subject headings
- Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 10 min after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start23 Feb 2018
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Noll, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451565
- Sponsor's protocol ID
- 7009
- Acronym
- HypoTAShoulder
- Status last verified
- Feb 2018
- First submitted
- 23 Feb 2018
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Systemic Arterial Hypotension Secondary to Beach Positioning : an Observational Study
- ClinicalTrials.gov ID
- NCT03451565
- Acronym / sponsor ID
- HypoTAShoulder / 7009
- Conditions
- Hypotension
- Keywords
- Hypotension, Systemic blood pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at describing the systemic arterial hypotension secondary to intraoperative beach chair positioning. This is a non-interventional prospective study.
The primary endpoint will be the intraoperative systemic arterial pressure measured at the arm.
The secondary endpoints will include postoperative mortality, intensive care admission, post anesthesia care unit length of stay,
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population studied will include patients operated at the University Hospitals of Strasbourg in a sitting position.
Key inclusion criteria (3 listed)
- Age above 18 years
- Patient operated in a sitting position at Hopitaux Universitaires de Strasbourg
- Patient willing to participate in the study
Key exclusion criteria (1 listed)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood pressure
Time frame: 10 min after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Noll, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Noll, MD (33 3 88 55 23 37, eric.noll@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 10 min after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.